Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT03887351
Status:
UNKNOWN
Last Update Posted:
2019-03-22
First Post:
2019-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frailty Heart Failure Study
Sponsor:
Jewish General Hospital
Organization:
Study Overview
Official Title:
Frailty in Community Dwelling Older Adults With Heart Failure
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective longitudinal cohort study aimed at measuring frailty and its associated risk factors community dwelling older adults aged 65 years or older.
The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities.
The primary outcome is all-cause mortality at 1-year post enrollment.
The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities.
The primary outcome is all-cause mortality at 1-year post enrollment.
Detailed Description:
The overarching research question is as follows: Is frailty predictive of patient-centered outcomes in older adults with heart failure (HF)? Hypotheses regarding this research question are: 1) Frailty is associated with increased 12-month mortality, 2) Frailty is associated with increased 3-month mortality or unplanned hospitalization, 3) Frailty is associated with lower baseline health-related quality of life (HrQOL), and 4) Frailty is associated with worsening HrQOL at 3 months.
There are three specific study objectives. 1) To compare the ability of various frailty measures to predict all-cause mortality, hospitalizations, and HrQOL in patients attending an outpatient HF clinic. 2) To examine the determinants of longitudinal changes in frailty measures over time. Lastly, 3) To examine the clinical and frailty related determinants of fatigue in older adults
A prospective longitudinal cohort study will be conducted at a specialized heart failure (HF) clinic at the Jewish General Hospital (JGH) and Royal Victoria Hospital (RVH). The study aims to measure frailty and its associated risk factors in community dwelling individuals, aged 65 years or older and who have been diagnosed with HF (preserved or reduced ejection fraction) for at least 3 months. The multi-domain geriatric assessment will include questionnaires administered by interview, physical performance tests, body composition analysis using a bioimpedance machine, review of clinically acquired biochemical and imaging tests, and chart review. The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities. Baseline assessment will approximate to 40 minutes of patient contact time while follow up phone interviews at 3 and 12 months will approximate to 20 minutes. Outcome measures such as all-cause mortality, HrQOL, unplanned hospitalization will be assessed at 3 months and 1-year post enrollment.
There are three specific study objectives. 1) To compare the ability of various frailty measures to predict all-cause mortality, hospitalizations, and HrQOL in patients attending an outpatient HF clinic. 2) To examine the determinants of longitudinal changes in frailty measures over time. Lastly, 3) To examine the clinical and frailty related determinants of fatigue in older adults
A prospective longitudinal cohort study will be conducted at a specialized heart failure (HF) clinic at the Jewish General Hospital (JGH) and Royal Victoria Hospital (RVH). The study aims to measure frailty and its associated risk factors in community dwelling individuals, aged 65 years or older and who have been diagnosed with HF (preserved or reduced ejection fraction) for at least 3 months. The multi-domain geriatric assessment will include questionnaires administered by interview, physical performance tests, body composition analysis using a bioimpedance machine, review of clinically acquired biochemical and imaging tests, and chart review. The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities. Baseline assessment will approximate to 40 minutes of patient contact time while follow up phone interviews at 3 and 12 months will approximate to 20 minutes. Outcome measures such as all-cause mortality, HrQOL, unplanned hospitalization will be assessed at 3 months and 1-year post enrollment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: